This blog replaces the earlier archives I had posted on the Internet and includes various memos sent to the clients of the VitaminLawyer.com (now the Vitamin Consultancy). It includes archived copies of memos from 2004 through 2007 and subsequent memos will be posted as they are issued.

Tuesday, February 16, 2010

0. Blog & News – URGENT FUNDING NEEDED1. FDA Warning Letter Trends2. Product Expiration Dates3. Natural Clinical Trials Center4. New Webinar on Copy Writing Planned5. Archived Vitamin Lawyer Webinars-----------------------------------------------------Blog & News – URGENT FUNDING NEEDEDYou’ve
heard about the “Stop the Shot” lawsuit aimed at de-licensing the H1N1
and other “seasonal” flu vaccines. We were in Court in DC in November,
and New York backed off its health care workers’ mandate, leaving us
without legal "standing" to challenge the vaccine licenses. Then we were
heading back to Court in December, but New Jersey backed off its
licensed child care mandate… As the Judge said, “Your clients are
winning…” but we still did not have “standing” to challenge the FDA’s
illegal approvals of the flu vaccines!The November Case: Lawyers Video Reportwww .healthfreedomusa .org/?p=3933The NJ Case: www .healthfreedomusa .org/?p=3970WELL,
WE ARE READY TO GO BACK TO COURT – with new mandated clients --
however, this time we are not “telegraphing our punches” by announcing
our clients in advance! Last night I emailed the 13 documents, two of
them over 30 pages each, which will make up the initial filing, to our
lawyers in DC who will actually file the case.IT’S
TIME TO FUND THE “STOP THE SHOT” LITIGATION. I don’t think I need to
dwell on the importance of “putting down” Big Pharma’s vaccine gambit to
the natural products industry.
The H1N1 vaccines is the perfect example of Obamacare in action: the
govt bought $6.4 billion of vaccines, then the govt (FDA) approved the
vaccines (we say, “Illegally!”) then the govt (CDC) recommended the
vaccines and then the govt (HHS) distributed them… all without following
their own drug approval rules.This
type of litigation is expensive. So far it’s been mostly done with
volunteer work, but now the lawyers in DC need some funding to cover the
cost of their associate who is actually doing the leg work. We also
need to cover the filing fees. Natural Solutions covered the filing fees
in November. Our ally Gary Null is covering his lawyer’s costs. WE NEED
YOUR HELP TO COVER THE DC LAWYERS.IF
YOU ARE WILLING TO DONATE FOR THIS PURPOSE, please call me or email me
immediately. We need to talk. Even donations as little as $100 will
help; a couple $1,000 donations would go a long way. But, the total cost
of this case could be a hundred grand or more.‘Nough said. Anyone out there willing to make this happen? I promise you, it will be money well invested. 973.300.4594-----Access to the Vitamin Lawyer Webinars and more:www .NaturalHealthOptions .netDr. Rima Recommends: new web sitewww .DrRima .netMore Madness from DC: McCain attacks Dietary SupplementsWhile Harkin attacks Foods… all under the guise of “safety…”www .healthfreedomusa .org/?p=4683And this on the Vitamin Lawyer blog:vitaminlawyerhealthfreedom.blogspot .com/2010/02/fake-food-and-supplement-safety-bills.html
[Please note: all URLs in this memo are "broken" with spaces inserted
to avoid the memo being treated as "spam" by certain email service
providers.]-----------------------------------------------------1. An Analysis of Warning Letter Trends [from: FDA News]“With
the FDA issuing warning letters at the rate of one-and-a-half per day
in 2009 — a 23% increase over 2008 — now isn't the time to face the FDA
unprepared!“FDA
[News]… has analyzed data from FDA warning letters to better understand
what problems the FDA most often cites. [We] found FDA inspectors
focusing on the following six themes in their inspections:# CAPA# International Harmonization# Supplier Management# Postapproval Controls# Records Controls# Swifter Enforcement …“Manufacturing
and Quality. Production record review and quality laboratory controls
topped the list of citations addressed by warning letters, but five
other key areas were also cited in more than 25 percent of
quality-related warning letters.“Advertising
and Marketing. FDA more than doubled the number of advertising-related
warning letters it produced last year, and the agency is promising there
will be no letup in the intensity of its enforcement.“Clinical
Trials. Clinical trial regulations were the subject of more than 20
warning letters in 2009. Investigators were cited for inadequate
informed consent and failing to take case histories; IRBs were cited for
failing to document their actions and maintain adequate policies; and
sponsors were faulted for failure to fulfill general responsibilities
and stop out-of-compliance investigators.”-----------------------------------------------------2. Product Expiration DatesAs
you may be aware from previous issues of the Vitamin Lawyer Update
eMemo, the FDA does NOT require dietary supplement manufacturers to put
an “expiration” or “best used by” date on product packaging. It does
require, however, if you do so, you must have “competent and reliable”
substantiation for that date! With the cGMP requirement that your
manufacturer keep product samples from each batch, over time, you may
develop such substantiation.But
what to do in the mean time? I suggest you remove any such dating from
bottles. One client decided to sell “expired” product at discount and
asked for my suggestion for a FAQ on the subject. Here is what I
suggested:“Some
of our customers have asked us about "expiration dates" on dietary
supplement bottles. It was traditional in the vitamin industry to
include "expiration" or "best to use by" dates on bottles, since dietary
supplements are foods and food product packing often has expiration
dates.“The
Food and Drug Administration (FDA) does NOT require such dating for
dietary supplements, and, under the FDA's revised "Good Manufacturing
Procedures" such dating is NOT permitted unless there is some good,
scientific reason to have an expiration date. We are therefore removing
unnecessary dating on our products to conform to current practices. “Some
of our product labels still contain such dating and where the dating
has "expired" but without any indication of actual need for such dating,
we are offering the products at discount. Should you receive a product
with an "expired" date and do not want to use the product, please return
it within 30 days of receipt for a full refund.”-----------------------------------------------------3. Natural Clinical Trials CenterCheck out the Videos and PPT Webinar on the Site!www .NaturalClinicalTrials .org•
New FDA and FTC regulations make your job harder than ever... Recent
changes mean that your company MUST consider Clinic Tests, Studies and
Trials:• To demonstrate product safety• To substantiate product claims• To determine "typical results" for Testimonial Ads• To meet batch testing requirements.• These changes also mean you must not:• Make claims you cannot substantiate• Use Testimonials without disclosing "typical results"•
What can you do to tell your customers that your product is helpful,
effective and important for them to use? Let us show you what we can do
to help you with cost-effective clinical work...Natural
Solutions Wellness Center has established the Natural Clinical Trials
Program - the NCT - to bring our special expertise to natural product
clinical studies, tests and trials.The
NCT Program is headed by Dr. Rima E. Laibow MD, with the collaboration
of Dr. Robert Goodman PhD, Ralph Fucetola JD, and the Natural Solutions
Staff.------------------------------------------------4. New Natural Solutions Webinar Planned – Coming this March“Writing Lawful Natural Products Ad Copy”Details will be posted at:www .NaturalHealthOptions .netwww .NaturalClinicalTrials orgIf
you want to reserve space for this Webinar, please email me at
ralph.fucetola (at) usa.net and put “Webinar” in the Subject line. The
expected price for the 2 hour event is $99.--------------------------------------------------------------5. Archived Natural Solutions Vital Connection Webinars with the Vitamin LawyerSetting up a Student Account at VCU is free and relatively easy:www. VitalConnectionUniversity. com[1] Your Ministry, the Law and Alternative PracticesHeld July 9, 2009: This webinar is Archived. – (approximately 2 hours)A
PowerPoint discussion with Counsel Ralph Fucetola JD about advanced
health care practices, the ministry and the law. $49.95 - Includes eBook
with forms.Direct sign-up: www. vitalconnectionuniversity. com/moodle/course/view.php?id=169[2] CAM Advanced Healthcare Practitioner SOPsHeld: May 6, 2009 – This Webinar is Archived.(approximately 2 hours)You can see my short introductory YouTube video at:vitaminlawyerhealthfreedom.blogspot. com/2009/02/webinar-announcement-ethical-legal.htmlDirect sign-up: http://www.vitalconnectionuniversity.com/moodle/course/view.php?id=84[3] Bringing New Natural Products to MarketHeld: May 10, 2009 – This Webinar is Archived.(approximately 2 hours)What
does it take to bring a new natural product to market? This webinar
will cover the pitfalls and requirements. Especially in the current
market, you need to do everything right to have a success… includes a
useful eBook with forms.Direct sign-up: www. vitalconnectionuniversity. com/moodle/course/view.php?id=102"Your papers must be in order."Are your ingredients "grandfathered" under DSHEA?Have you filed your Structure and Function Claims Notices?Do you have your SOPs (Standard Operating Procedures)Is your web site Site Use Statement up-to-date? Is your Substantiation Notebook ready?Your papers need to be in order before the FDA inspection![4] Sustainable IRAHeld: Saturday June 13, 2009 – This Webinar is Archived.(approximately 2 hours)Sustainable
Retirement Capacity - Protecting the Environment AND Your IRA/401 – At
the Same Time! The Foundation Trustees lead you through an interesting
slide presentation that will help you make important decisions about
where you want to be in the event conditions in the US continue to
deteriorate. Free Webinar ($25 donation suggested). With eBook.Direct IRA link: www. Vitalconnectionuniversity .com/moodle/course/view.php?id=95Each
Webinar includes its own useful eBook of forms and other information
that will help you better organize (includes full powerpoint
presentation text and resources).----------------------------------------------Our new affiliation site: www .naturalhealthoptions .comDo you have an affiliation program? We’d like to list it. If you don’t have an affiliate program… I have Affiliate Program SOPs & Rules …And good advice… for you.“One on One with the Vitamin Lawyer” from Power Pictures Inc.Trailer: www. youtube. com/watch?v=wWPvzpn0YgAwww. powerpicturesinc. net/store.htmlFollow me on Twitter - www. twitter. com/healthfreedomus-----The Vitamin Lawyer's SOP Outline Page: http: //tinyurl. com/2eu6yjCurrent SOP Project: CAPACorrective and Preventative Actions Standard Operating ProceduresCAPA is an essential element in cGMP SOPs. Outline below; let me know if you need a formal SOP. Main Headings of the CAPA SOPDiscovery of the DeviationDocumentation of the EventImmediate Corrective ActionInvestigation of the Primary CauseCausal AnalysisCorrective ActionEffectiveness Evaluation-----Current Webinar Project: Writing Lawful Ad Copy (March)Ralph Fucetola JDwww .NaturalHealthOptions .netwww .vitaminlawyer .comhttp:// vitaminlawyerarchives .blogspot .comwww .globalhealthfreedom. orgIf
you want to unsubscribe to this newsletter, please email me at
ralph.fucetola (at) usa.net with “Unsubscribe” in the subject line.

Wednesday, February 3, 2010

0. Blog & News – CAPA1. Top Ten Web Trends for 20102. Natural Clinical Trials Center3. New Webinar on Copy Writing Planned4. Archived Vitamin Lawyer Webinars-----------------------------------------------------Blog & News – Access to the Vitamin Lawyer Webinars and more:www .NaturalHealthOptions .netDr Rima writes Forbes on Vaccination:www .healthfreedomusa .org/?p=4568Dr Rima Reports on Panama Eco Project:www .healthfreedomusa .org/?p=4554CAPA SOPs– Corrective and Preventative Actions Standard Operating ProceduresCAPA is an essential element in cGMP SOPs. Outline below; let me know if you need a formal SOP. Main Headings of the CAPA SOPDiscovery of the DeviationDocumentation of the EventImmediate Corrective ActionInvestigation of the Primary CauseCausal AnalysisCorrective ActionEffectiveness Evaluation
[Please note: all URLs in this memo are "broken" with spaces inserted
to avoid the memo being treated as "spam" by certain email service
providers.]-----------------------------------------------------1.
From EntireWeb.com: “It's never been harder to keep up with the latest
web trends - with the expansion onto mobile platforms, the growth of
social media and the need for start ups to be aware of new SEO
techniques.” Here are some excerpts:
… Constructing a mobile website, creating social media campaigns and
selling online are just some of the challenges businesses will face
during 2010. Here are top online trends for the next 12 months.Mobile web

Every
web-savvy business knows smartphone use is on the rise. But few are
actively developing for mobiles by creating websites specifically used
for handheld devices.

As
more and more mobile users flock to gadgets with larger touchscreens
and internet browsers, such as the iPhone or Google Nexus One, the
mobile space will become bigger and SMEs need to get on board. If your
website isn't accessible through a smartphone or app, users will give up
and go somewhere else - losing you traffic and potential sales.

Ovum
analyst Nathan Burley says the number of people taking up smartphones
instead of traditional handsets will require businesses to develop
mobile websites.

"In
our view there are two big trends that will occur in 2010. That is
mobile broadband and the adoption of smartphones, and the impact of
those two things on the industry. This is changing the way people access
the internet, and that is in mobile." …SEO

Using
search engine algorithms in order to get your site on "page one" has
been a tactic used by online businesses for years. But SEO experts say
the process of getting a website known will become even harder in 2010
with the rise of personalised and real-time search.

Social
network Twitter sparked a trend when it designed the first popular
real-time search engine. When users search for a term, the site would
update that search with new "tweets" as they were being made.

Google
has recently introduced a real-time search function of its own,
complete with indexed tweets, while Microsoft Bing has made a deal to
show tweets in search results. …Social Media

Facebook
and Twitter were the standout social networks from 2009, and their
popularity will surge in 2010 with both introducing new features,
including paid accounts for business.

But
businesses need to pay attention to the trends on these sites. Creating
a social media strategy is no longer optional, it is vital to the
health of a company and its ability to tap into an online user-base. …Online retail

More
and more Australian businesses are selling online, but compared to the
US we have a lot of catching up to do. Online spending has grown from 1%
to 3% of overall spending over the last 10 years, compared to the
American equivalent of 7%. …Advertising

The
internet advertising industry continued to grow in 2009 and will do the
same in 2010, but the next 12 months is expected to see the ongoing
development of mobile advertising.

Last
year the Interactive Advertising Bureau forecast the online ad market
to pass $2 billion by next month, representing a 27% increase from 2008.
While the downturn forced spending down in 2009, it's safe to assume
that figure will rise in 2010. …Reputation management

Most
businesses are at least operating a website, but even those rejecting
the online space need to be aware of how fast rumours and allegations
can fly in the digital age. Several companies have had their reputations
tarnished within hours from the activities of either rogue employees,
or a botched advertising campaign.

Griffin says businesses need to control their reputation by monitoring what people are saying about them.

… "Auditing, monitoring and analysing social media platforms along with
risk mitigation strategies will become standard fare for those
companies looking to protect and enhance their brand on social media
platforms." …Marketing

While
mobile advertising may be taking awhile to heat up, many businesses are
developing new and interesting mobile marketing campaigns to draw
people into their stores.

Google
has developed a system whereby users take a picture of a barcode with
their mobile phone and use the search engine to find information. Closer
to home, Hoyts Cinemas currently runs a promotion where movie goers
with Bluetooth activated on their handsets sometimes receive discount
offers via text messages when they walk into a lobby. …

Thomas
also says a number of companies will begin to commission mobile apps,
especially on the iPhone, purely for marketing purposes. Whether this
will gain them revenue or purely open their brand to a new audience, the
mobile apps market will become part of an online business's marketing
strategy in 2010.Content

The
growth of the internet has allowed businesses to publish content of
their own, including blogs, pictures and even videos. King says SMEs
should think about creating some sort of content on YouTube or similar
sites such as a tutorial, and see a fan base grow. …Open Source

Once
upon a time, businesses wouldn't trust open-source programs in favour
of branded, more trustworthy software solutions. But now open-source has
given SMEs a way of operating high-end programs without substantial
costs. …Cloud computing

Two
years ago "cloud computing" was viewed by many businesses as a buzzword
with no particular meaning, used by tech-heads who didn't quite know
what they were talking about.

Now,
using cloud services has become an essential for businesses. Whether
they are backing up their data or using a piece of software hosted on
external servers, cloud computing is now a part of everyday operations
for many SMEs. …

"Using
cloud resources does not eliminate the costs of IT solutions, but does
rearrange some and reduce others. In addition, consuming cloud services
enterprises will increasingly act as cloud providers and deliver
application, information or business process services to customers and
business partners."Author: Patrick Stafford – SmartCompany .com.au www .entireweb .com/newsletter/archive/2010/PRINT597.html-----------------------------------------------------2. Natural Clinical Trials CenterCheck out the Videos and PPT Webinar on the Site!www .NaturalClinicalTrials .org•
New FDA and FTC regulations make your job harder than ever... Recent
changes mean that your company MUST consider Clinic Tests, Studies and
Trials:• To demonstrate product safety• To substantiate product claims• To determine "typical results" for Testimonial Ads• To meet batch testing requirements.• These changes also mean you must not:• Make claims you cannot substantiate• Use Testimonials without disclosing "typical results"•
What can you do to tell your customers that your product is helpful,
effective and important for them to use? Let us show you what we can do
to help you with cost-effective clinical work...Natural
Solutions Wellness Center has established the Natural Clinical Trials
Program - the NCT - to bring our special expertise to natural product
clinical studies, tests and trials.The
NCT Program is headed by Dr. Rima E. Laibow MD, with the collaboration
of Dr. Robert Goodman PhD, Ralph Fucetola JD, and the Natural Solutions
Staff.------------------------------------------------3. New Natural Solutions Webinar Planned – Coming this March“Writing Lawful Natural Products Ad Copy”Details will be posted at:www .NaturalHealthOptions .netwww .NaturalClinicalTrials orgIf
you want to reserve space for this Webinar, please email me at
ralph.fucetola (at) usa.net and put “Webinar” in the Subject line. The
expected price for the 2 hour event is $99.--------------------------------------------------------------4. Archived Natural Solutions Vital Connection Webinars with the Vitamin LawyerSetting up a Student Account at VCU is free and relatively easy:www. VitalConnectionUniversity. com[1] Your Ministry, the Law and Alternative PracticesHeld July 9, 2009: This webinar is Archived. – (approximately 2 hours)A
PowerPoint discussion with Counsel Ralph Fucetola JD about advanced
health care practices, the ministry and the law. $49.95 - Includes eBook
with forms.Direct sign-up: www. vitalconnectionuniversity. com/moodle/course/view.php?id=169[2] CAM Advanced Healthcare Practitioner SOPsHeld: May 6, 2009 – This Webinar is Archived.(approximately 2 hours)You can see my short introductory YouTube video at:vitaminlawyerhealthfreedom.blogspot. com/2009/02/webinar-announcement-ethical-legal.htmlDirect sign-up: http://www.vitalconnectionuniversity.com/moodle/course/view.php?id=84[3] Bringing New Natural Products to MarketHeld: May 10, 2009 – This Webinar is Archived.(approximately 2 hours)What
does it take to bring a new natural product to market? This webinar
will cover the pitfalls and requirements. Especially in the current
market, you need to do everything right to have a success… includes a
useful eBook with forms.Direct sign-up: www. vitalconnectionuniversity. com/moodle/course/view.php?id=102"Your papers must be in order."Are your ingredients "grandfathered" under DSHEA?Have you filed your Structure and Function Claims Notices?Do you have your SOPs (Standard Operating Procedures)Is your web site Site Use Statement up-to-date? Is your Substantiation Notebook ready?Your papers need to be in order before the FDA inspection![4] Sustainable IRAHeld: Saturday June 13, 2009 – This Webinar is Archived.(approximately 2 hours)Sustainable
Retirement Capacity - Protecting the Environment AND Your IRA/401 – At
the Same Time! The Foundation Trustees lead you through an interesting
slide presentation that will help you make important decisions about
where you want to be in the event conditions in the US continue to
deteriorate. Free Webinar ($25 donation suggested). With eBook.Direct IRA link: www. Vitalconnectionuniversity .com/moodle/course/view.php?id=95Each
Webinar includes its own useful eBook of forms and other information
that will help you better organize (includes full powerpoint
presentation text and resources).----------------------------------------------Natural Clinical Trials – www .NaturalClinicalTrials .orgOur new affiliation site: www .naturalhealthoptions .comDo you have an affiliation program? We’d like to list it. If you don’t have an affiliate program… I have Affiliate Program SOPs & Rules …And good advice… for you.“One on One with the Vitamin Lawyer” from Power Pictures Inc.Trailer: www. youtube. com/watch?v=wWPvzpn0YgAwww. powerpicturesinc. net/store.htmlFollow me on Twitter - www. twitter. com/healthfreedomusThe Vitamin Lawyer's SOP Outline Page: http: //tinyurl. com/2eu6yjCurrent SOP Project: CAPA: Correction and Prevention AnalysisCurrent Webinar Project: Writing Lawful Ad Copy (March)Ralph Fucetola JDwww .NaturalHealthOptions .netwww .vitaminlawyer .comhttp:// vitaminlawyerarchives .blogspot .comwww .globalhealthfreedom. orgIf
you want to unsubscribe to this newsletter, please email me at
ralph.fucetola (at) usa.net with “Unsubscribe” in the subject line.

About Me

The Vitamin Conslutancy - www.vitaminconsultancy.com -- I practiced law for 36 years in NJ (1971 - 2006), gaining a reputation as The Vitamin Lawyer, representing people in the Natural Products, Dietary Supplements and CAM (Complementary and Alternative Modalities) fields. Now I provide educational services and I consult with lawyers and other professionals, formulators, manufacturers and purveyors of natural and nutritional products, as well as with CAM enterprises and practitioners.
I started these blogs to comment on health and freedom issues and to provide an archive of information for my clients and associates. This is a private expressive association communication.
I have been a trustee of several NGOs (nongovernmental organizations) including the Natural Solutions Foundation - globalhealthfreedom.org - Institute for Health Research - inhere.org - Sound Health Research Institute - soundhealthresearch.org and LifeSpirit Church - lifespirit.org